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The Economic Times

Economy / The Economic Times

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Drug regulator steps up oversight on product changes after approval

Drug makers now need government approval for any quality changes to medicines. This applies to alterations affecting a drug's identity, strength, quality, purity, or potency. The regulator is strengthening manufacturing standards through risk-based audits and more inspections. This ensures only safe and effective medicines reach consumers. Manufacturers must inform the drug regulator about changes in manufacturing, packaging, or shelf life.

6 Feb 2026 12:17 am